Efficacy and Safety of NT 201 in the Treatment of Lateral Periorbital Wrinkles

A Prospective, Randomized, Double-Blind, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 in Comparison to Placebo and to Compare Two Different Application Schemes of NT 201 in the Treatment of Lateral Periorbital Wrinkles

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00541723

Enrollment

111

Registered

2007-10-10

Start date

2007-09-30

Completion date

2008-05-31

Last updated

2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral Periorbital Wrinkles

Brief summary

To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile and to compare two different application schemes of Xeomin. Each subject will be treated on the right and left eye area, using the same dose but different application schemes (i.e. 3 or 4 injection sites).

Detailed description

Conducted in Europe

Interventions

DRUGIncobotulinumtoxinA (Xeomin)

Intramuscular injection at day 0, at 3 and 4 injection sites per eye (4 x 3 or 3 x 4 units = 12 units per eye)

DRUGPlacebo

Intramuscular injection at day 0, at 3 and 4 injection sites per eye.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

Main Inclusion Criteria: \- Moderate (grade 2) to severe (grade 3) symmetrical lateral periorbital wrinkles assessed by the investigator according to the 4-point scale at maximum smile Main

Exclusion criteria

\- Significant facial asymmetry

Design outcomes

Primary

Measure	Time frame	Description
Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline.	Week 4	Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.

Secondary

Measure	Time frame	Description
Response assessed by the investigator at maximum smile for either eye area compared to baseline.	Weeks 2, 4, 12, and 20	Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.
Response assessed by the subject's global assessment at maximum smile for either eye area compared to baseline.	Weeks 2, 4, 12, and 20	Responder: subjects with at least a moderate improvement, i.e. a score of at least +2 on a 9 point Likert scale.

Countries

France, Germany, Italy, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026